Clinical trial · Interventional
Irreversible Electroporation(IRE) For Unresectable Urinary Bladder Neoplasms
Irreversible Electroporation(IRE) For Unresectable Urinary Bladder Neoplasms: Phase I and Phase II Clinical Trial
NCT02430623CI-TRIAL-00053684IREcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Urinary Bladder Neoplasms.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Urinary Bladder Neoplasms | Bladder Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irreversible electroporation (IRE) | Procedure | — | UNRESOLVED |
| NanoKnife | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IRE Group
- description
- irreversible electroporation for Unresectable Urinary Bladder Neoplasms
- interventionNames
- Procedure: Irreversible electroporation (IRE)
- Device: NanoKnife
- type
- NO_INTERVENTION
- label
- Control
- description
- The patients without treatment
Primary outcomes (1)
- measure
- Number of participants with Adverse events
- timeFrame
- 6 month
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Head and Urinary Bladder diagnosed by positive biopsy or non-invasive criteria, * Not suitable for surgical resection, * Eastern Cooperative Oncology Group (ECOG) score of 0-1, * A prothrombin time ratio \> 50%, * Platelet count \> 80x10\^9/L, * Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure, * Able to comprehend and willing to sign the written informed consent form (ICF), * Have a life expectancy of at least 3 months. Exclusion Criteria: * Cardiac insufficiency, ongoing coronary artery disease or arrhythmia, * Any active implanted device (eg Pacemaker), * Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception, * Have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System, * Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.
References
Publications (0)
Data not yet available
No reference posted for this study.